<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809643754378</udiDi>
    <basicUdiDi>B-08809643754378</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [S-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0805</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754385</udiDi>
    <basicUdiDi>B-08809643754385</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [S-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0807</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754392</udiDi>
    <basicUdiDi>B-08809643754392</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [S-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0809</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754408</udiDi>
    <basicUdiDi>B-08809643754408</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [S-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM1005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754415</udiDi>
    <basicUdiDi>B-08809643754415</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0604</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754422</udiDi>
    <basicUdiDi>B-08809643754422</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0605</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754439</udiDi>
    <basicUdiDi>B-08809643754439</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0606</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754446</udiDi>
    <basicUdiDi>B-08809643754446</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0607</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754453</udiDi>
    <basicUdiDi>B-08809643754453</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0608</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754460</udiDi>
    <basicUdiDi>B-08809643754460</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0609</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754477</udiDi>
    <basicUdiDi>B-08809643754477</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:50.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754484</udiDi>
    <basicUdiDi>B-08809643754484</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0612</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754491</udiDi>
    <basicUdiDi>B-08809643754491</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0804</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754507</udiDi>
    <basicUdiDi>B-08809643754507</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0805</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754514</udiDi>
    <basicUdiDi>B-08809643754514</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0807</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754521</udiDi>
    <basicUdiDi>B-08809643754521</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0809</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754538</udiDi>
    <basicUdiDi>B-08809643754538</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM0812</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754545</udiDi>
    <basicUdiDi>B-08809643754545</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDM1005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754552</udiDi>
    <basicUdiDi>B-08809643754552</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM0604F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754569</udiDi>
    <basicUdiDi>B-08809643754569</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM0605F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:49.838Z</lastUpdated>
  </row>
</eudamedExport>